The following data is part of a premarket notification filed by Kensey Nash Corp. with the FDA for Modification To Copios Bone Void Filler Sponge & Paste.
| Device ID | K072384 |
| 510k Number | K072384 |
| Device Name: | MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Contact | Jennifer J Bosley |
| Correspondent | Jennifer J Bosley KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-24 |
| Decision Date | 2007-09-21 |
| Summary: | summary |